[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566465":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fundación para la Investigación del Hospital Clínico de Valencia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","SHAM_COMPARATOR","Patients allocated to this arm will receive the standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training.",[13],"Behavioral: Usual Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Supervised aerobic plus moderate to high-intensity strenght training","ACTIVE_COMPARATOR","Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training.",[19],"Behavioral: Exercise Program",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Exercise Program","Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual Care","Patients allocated to this arm will receive standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. They will also receive a weekly phone call and an in-person monthly visit to monitor exercise training performance.",[9],[32],{"name":33,"affiliation":34,"role":35},"Laura López Bueno, PhD","Instituto de Investigacion Sanitaria INCLIVA","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Laura López Bueno","CONTACT","650682744","Laura.Lopez@uv.es",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"Hospital Clínico Universitario de Valencia","Valencia","46010","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],-0.37966,39.47391,{"lat":53,"lon":52},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100566465","effects-of-an-exercise-program-in-women-over-60-yr-with-hfpef-and-sarcopenia-on-functional-capacity-and-quality-of-life-100566465",false,"NCT06655532","Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life","Effects of a Concurrent Training-based Exercise Program in Women Over 60 Years With Heart Failure With Preserved Ejection Fraction and Sarcopenia on Functional Capacity, Quality of Life and Cognitive Function","TRAIN-SARC","Inclusion Criteria:\n\n* Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>125 pg\u002FmL, inthe last month.\n* Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.\n* Age ≥ 60 years old.\n* The participant is willing to give informed consent to participate in the study.\n* SARC-F score ≥4 points.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline cardiopulmonary exercise test.\n* Cardiac pacemaker.\n* Significant primary moderate-to-severe valve disease.\n* Effort angina or signs of ischemia during CPET.\n* Primary cardiomyopathies.\n* Cardiac transplantation.\n* Any other comorbidity with a life expectancy of less than one year.","FEMALE","60 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"NA","This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.\n\nAfter randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation \\[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL\u002Fkg\u002Fmin (SD±2)\\] of 40 patients (20 per arm) would be necessary to test our hypothesis.",[75,76,77],"Heart Failure With Preserved Ejection Fraction (HFpEF)","Sarcopenia","Women",[79,76,80,81,82,77],"Heart Failure with Preserved Ejection Fraction","Cardiovascular Diseases","Heart Diseases","Heart Failure","NOT_YET_RECRUITING","2024-10-23",{"date":86,"type":87},"2024-10-26","ACTUAL",{"date":89,"type":69},"2024-11-04",{"date":91,"type":69},"2026-01-30",{"name":5,"class":6},1]